# K110166: Clearcut S Safety Knife

- Pathway: 510(k) (Abbreviated)
- Applicant: Alcon Research, Ltd.
- Decided: May 20, 2011 after 120 days
- Product code: HNN (Knife, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Beaver Safety Knife: named in the summary without a submission number
- (no number) KAI Safety Knife: named in the summary without a submission number
- (no number) Diamatrix ProTekt Safety Knife: named in the summary without a submission number

## Recalls of this device
- Apr 22, 2024 · Class II · Z-1925-2024: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Apr 22, 2024 · Class II · Z-1923-2024: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Apr 22, 2024 · Class II · Z-1924-2024: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Apr 22, 2024 · Class II · Z-1922-2024: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.

## Indications for use
ClearCut S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.

Source page: https://510kreport.com/device/K110166
Methodology: https://510kreport.com/methodology